Z-1889-2026Class II

Medline Industries, LP

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-29

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Firm state

Product quantity

270,311 total

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

Product description

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

Code / lot info

DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895

Other recalls SPEQ maps to Documentation & Change Control

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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.